YBB0026xx包装材料红外光谱测定法英文

YBB0026xxYBB0026xx包装材料红外光谱测定法英文包装材料红外光谱测定法英文 State Food and Drug Administration NationalStandard forPharmaceutical Containers Materials Tentative YBB0026xxThe Test Method for Infrared Spectrum in Packaging Material This Method is applicable for the infrared spectrum testing of themajor ingredientsin plasticand rubberpharmaceutical packaging materials Principles The infrared spectrum testingmethod isan effectivemeasure foridentifying andanalyzing thechemical positionof amaterial After akind ofchemical istreated withinfrared radiation the molecularvibration andspinning movementswill transitfrom alower energy level toa higherenergylevel causing theselective absorptionof infraredradiation with a certainfrequency and the generationof an infrared absorptionspectrum withcharacteristic features The intermediateinfrared region 4000to400cm 1 isamonly usedregion Infrared Spectroscopyfor PackagingMaterials This includes thetesting methodsand the sample preparationtechniques The testing methods include the transmissionmethod the attenuated total reflectance ATR method etc The transmissionmethod isused toobtain the infrared spectrumby measuringthe changein theintensity of the infrared light beforeand aftertransmitting througha sample The ATRmethod isused toobtain thereflectance spectrumof infrared light aftergoing intoa piece of ATRcrystal ina certainincidence angleand reflectedfor multipletimes on the surface of the sample attachedto the crystal Thisincludessingle pointattenuatedtotal reflectance andplane attenuatedtotal reflectance The sample preparation methodsincludethehot coatingmethod the thinfilm method the thermalcracking method the attenuatedtotalreflectancemethod the infrared microscope method etc Instrument FunctionsInstruments shall be calibratedwith apiece ofpolystyrene film 0 05mm inthickness 1 Calibrate the instrument wavewith2851cm 1 1601cm 1 1028cm 1and907cm 1 The difference allowed within the range of2000 400cm 1is 4cm 1and thedifferenceallowedwithin the rangeof4000 2000cm 1is 8cm 1 2 For theresolution of the instrument it shall be able to clearlydistinguish7peaks withintherangeof3110 2850cm 1 The resolutiondepth betweenthe absorptionbelts of2924cm 1and2851cm 1shall beno less than18 transmittance and the absorptionbelts of1601cm 1and1583cm 1shall beno less than8 transmittance Unless otherwisespecified the labeledresolution of theinstrumentshall beno lessthan2cm 1 Environment ConditionsThe temperatureshall be15to30 and therelative humidityshall belessthan65 Appropriate levelof ventilationshallbe used toavoid theaumulation oftoo muchcarbon dioxideand organicsolvent vapors Method I Thermal CoatingMethod This method is applicable to the infraredspectrum testing for granules plastic bottlesand singlelayer films Heat apieceofpotassium bromidecrystal orsodium chloridecrystal with an alcohol burner oran electricheater withtemperature control make the temperature closeto themelting pointof the material insert the sample whileit isstill hotinto thepotassium bromidecrystal orsodium chloridecrystal no smokeshould begenerated and record the infraredspectrum after introducing aninfrared light Method II Thin FilmMethod This method isapplicable to the infraredspectrum testingfor granules plastic bottlesand singlelayer films Take about0 25g ofthe sample which can be cutinto smallpieces add about10ml of an appropriatesolvent toluene can be used for suchmaterials asPE PP EVA etc 1 1 2 2 tetrachloroethane can be usedfor PET and dichloroethanecan beusedforPC reflux ata high temperature toallow thedissolution ofthe sample smear therefluxed solutiononto thepotassium bromidecrystal orsodium chloridecrystal with a capillarywhile thesolution isstill hot heat itto removethe solventand recordthe infraredspectrum afterintroducing aninfrared light Method III Thermal CrackingMethod Thismethod isapplicable tothe infraredspectrum testingfor rubberproducts Take about3g ofthe sample cut itinto smallpieces extract themfor8hours withacetone oranother appropriatesolvent dry themat80 place0 1to0 2gofthesamplepieces atthe bottomof acracking tube and movethe crackingtube heldwithatest tubeclamp horizontallyto analcoholburnerfor heating After thecondensate ofthe crackingproducts areobtained onthe coolingend ofthe crackingtube smear itonthepotassium bromidecrystal orsodium chloridecrystal witha capillaryand immediatelyrecordthe infraredspectrum afterintroducing aninfraredlight Method IV Attenuated TotalReflectance Method Thismethod isapplicable tothe infraredspectrum testingforgranules plastic bottles films hard sheetsand rubberproducts Take anappropriate amountofthesample withclean andeven surfaces press ittightly againstthecrystal ZnSe crystalorthecrystal ofthallium bromideand thalliumiodide ina ratioof1 1 KRS 5 used inthe ATRattachment anddirectly recordthe infraredspectrum afterintroducing aninfraredlight Method V Infrared MicroscopeMethod Thismethod isapplicabletotheinfraredspectrumtestingfor multiplelayer positefilms andposite hardsheets Cut thesample intothin sliceswith appropriatethickness lessthan50 m withacutter place themunder aninfraredmicroscopeto observetheir sections select theregion to be tested and recordtheinfraredspectrumafterintroducinganinfraredlight No tes onthe DraftingoftheTestMethodforInfraredSpectruminPackagingMateri alI Overview1 Source ofTask This Standardis establishedaording tothe relevantrequirements specifiedin Noticeon SatisfactoryEstablishment Revision Standards onPharmaceutical PackagingMaterials inxx YAOJIANZHUHAN xx No 26 issued bythe DrugRegistration Divisionof StateFoodandDrugAdministration 2 Purpose This Methodis establishedto furtherstandardize thetestingmethodsfor infraredspectrum identificationitems forpackagingmaterialsand facilitatethe actualoperations 3 Drafting Principles ThisMethodis draftedfollowing theformat ofChinese Pharmacopoeiareferencing Rubber Identification Infrared SpectrometricMethod ISO4650 1987 General Ruleson InfraredSpectrum Analysis GB T6040 xx Infrared Identification of Rubber GB T7764 xx andthe fourth edition of EuropeanPharmacopoeia toimprove theinfrared identificationmethods The sequenceof name principles instruments andmethod isfollowed II Notes onStandard Items 1 Method I Thermal CoatingMethod Thismethod is fast and simple Attention shallbe paidto temperaturecontrol duringoperations The samplescanbedeposed ifthetemperatureis toohigh 2 Method IIThin FilmMethod Thismethod isestablished referencingthefourtheditionofEuropean Pharmacopeia Attention shallbe paidthat thesolvent selectedshallbeabletosolve thematerial tobe testedunder a hightemperatureand atthe sametime itcan alsobe easily